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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Set, Administration, Intravascular
510(k) Number K000343
Device Name NAC Y-ADP
Applicant
The Kipp Group
930 Wanamaker Ave.
Ontario,  CA  91761
Applicant Contact GARY WERSCHMIDT
Correspondent
The Kipp Group
930 Wanamaker Ave.
Ontario,  CA  91761
Correspondent Contact GARY WERSCHMIDT
Regulation Number880.5440
Classification Product Code
FPA  
Date Received02/03/2000
Decision Date 03/01/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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